Consumer medicine information

Rozex Gel

Metronidazole

BRAND INFORMATION

Brand name

Rozex Gel

Active ingredient

Metronidazole

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Rozex Gel.

What is in this leaflet

This leaflet answers some common questions about ROZEX GEL. Please read this leaflet carefully before you start using the ROZEX GEL. It does not contain all the information available on this medicine. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of using ROZEX GEL against the benefits it might have for you. If you have concerns about using this medicine ask your doctor or pharmacist.

Keep this leaflet with your tube.You may wish to read it again later.

What ROZEX GEL is used for

ROZEX GEL is used for the treatment of inflammatory papules and pustules of rosacea. Skin affected by rosacea has one or more of the following features: a redness that looks like a blush; pimples; small knobbly lumps on the nose and/or thin red lines due to enlarged blood vessels.

The active ingredient in ROZEX GEL is metronidazole, which belongs to the class of medicines known as antiprotozoals and antibacterials.

It is not clear how ROZEX GEL works however it may have antibacterial and anti-inflammatory action.

Preparations which are applied to the skin such as ROZEX GEL can be used in combination with other oral medications prescribed by your doctor.

Ask your doctor if you have any questions about why ROZEX GEL has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use ROZEX GEL

When you must not use it

Do not use ROZEX GEL

  • if you have an allergy to metronidazole or any of inactive ingredients in the gel
  • if you have or ever have had a blood disorder
  • to treat your child’s skin problem. ROZEX GEL has not been studied for use in children
  • if you are pregnant. There are no well-controlled studies of therapy with ROZEX GEL in pregnant women.

Symptoms of an allergic reaction may include:

  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives of the skin, especially on the areas of the skin where the cream was applied.

Tell your doctor if you think you have an allergy.

Do not use ROZEX GEL after the use by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your doctor or pharmacist for disposal.

Before you start to use it

Tell your doctor if you are pregnant or plan to become pregnant. With not enough information available on effect of ROZEX GEL on pregnant women, ROZEX GEL is not recommended for use during pregnancy.

Tell your doctor if you are breast-feeding. Your doctor will discuss the risks and benefits of using ROZEX GEL while breast-feeding.

If you have not told your doctor about any of the above, tell him/her before treatment with ROZEX GEL.

Taking other medicines

Tell your doctor and pharmacist if you are using any other medicines, creams or ointments, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and ROZEX GEL may interfere with each other. Your Doctor and pharmacist may have more information on medicines to be careful with while using ROZEX GEL.

How to use ROZEX GEL

Things you must do

  • Wash and dry your hands before applying the gel.
  • Apply morning and evening to a dry, clean face.
  • Squeeze a small quantity of ROZEX GEL onto your fingertips and rub a thin film onto the affected areas.
  • Avoid getting ROZEX GEL into your eyes.
  • Use a sunscreen when exposure to the sun cannot be avoided.

ROZEX GEL is only for use on the skin.

Continue to use even though there may not be an immediate effect. Medicines can take several weeks to show an effect. The average period of treatment is usually three to four months. The recommended duration of treatment should not be exceeded.

While you are using ROZEX GEL

Things you must do

  • Tell all doctors and nurses who are treating you that you are using ROZEX GEL.
  • If you feel that ROZEX GEL is not helping your condition, tell your doctor or pharmacist.
  • Tell your doctor if you become pregnant while using ROZEX GEL.

Things you must not do

  • Do not use cosmetic products that contain alcohol or are abrasive.
  • Do not use medicated soaps. These may have an extra drying or irritant effect.
  • It is not known if ROZEX GEL can increase the likelihood of skin cancers developing in people who have excessive exposure to sunlight. Therefore you should avoid or minimise exposure of areas treated with ROZEX GEL to sunlight or other sources of UV light.
  • Unnecessary or prolonged use of ROZEX GEL should be avoided as the long-term safety is unknown.

Things you can do

  • Apply makeup over ROZEX GEL.
  • If you forget to apply ROZEX GEL use it again as directed, as soon as you remember.

Things to be careful of

ROZEX GEL should not come into contact with the eyes or mucous membranes. If accidental contact occurs, rinse thoroughly with water and pat dry.

Avoid conditions known to make rosacea worse such as hot, spicy foods, alcohol, extremes of temperature and excessive exposure to sunlight.

Use ROZEX GEL less frequently if your face becomes hot, red, itchy or swollen.

Do not exceed the recommended duration of treatment.

Stop using ROZEX GEL and see your doctor if the problem persists

Side effects

Tell your doctor or pharmacist as soon possible if you do not feel well whilst you are using ROZEX GEL.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dry skin
  • superficial reddening of skin
  • severe itching of the skin
  • skin discomfort (burning,dryness, pain of skin/stinging)
  • skin irritation
  • worsening of rosacea
  • hyperpigmnentation and other pigmentation disorders

These are more common side effects of ROZEX GEL.

Tell your doctor or pharmacist if you notice any of the following:

  • contact dermatitis
  • reduced sense of touch or sensation
  • tingling or pricking sensation (‘pins and needles’)
  • numbness in the extremities
  • dysgeusia (metallic taste)
  • hypoesthesia (reduced sense of touch or sensation)
  • paraesthesia (pins and needles)
  • seborrhea (red, itchy rash and white scales)
  • sunburn
  • skin infection
  • hives
  • gastritis
  • bronchitis
  • stuffy, runny nose
  • skin exfoliation
  • swelling face
  • nausea
  • excess watery fluid collection on the face or eyelids

These are uncommon side effects of ROZEX GEL.

Tell your doctor or pharmacist if you notice any of the following:

  • hypothyroidism
  • Bursitis (inflammation or irritation of bursa)
  • Myalgia (muscle pain)
  • osteoporosis
  • conjunctivitis
  • abscess

These are rare side effects of ROZEX GEL.

Other side effects not listed above may occur in some patients. Do tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

In case of accidental swallowing
Immediately telephone your doctor or Poisons Information Centre on 13 11 26 for advice if in Australia.

Ingredients

Each gram of ROZEX GEL contains:
7.5 mg/g of metronidazole as the active ingredient.

Inactive ingredients:
methyl hydroxybenzoate ,
propyl hydroxybenzoate ,
disodium edetate,
Carbomer 940,
propylene glycol,
sodium hydroxide to adjust pH,
purified water q.s. to 1.0g.

After using ROZEX GEL

If you have queries about any aspect of your medicine, or any questions regarding the information in this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep the medicine in a cool dry place where the temperature stays below 25°C.

Do not store it, or any other medicine, in a bathroom, near a sink, or on a window-sill.

Do not leave it in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines

Disposal

If your doctor tells you to stop using ROZEX GEL or it has passed its expiry date, ask your pharmacist what to do with any that is left over. Return any unused medicine to your pharmacist.

Product description

What it looks like

ROZEX GEL is a homogeneous gel in an aluminium tube with a screw cap containing 2g, 5g, 15g, 30g and 50g of gel.

Not all pack sizes may be available.

Sponsor

Galderma Australia Pty Ltd
Suite 4,13B Narabang Way
Belrose NSW 2085
Ph: 1800 800 765

Distributed in New Zealand by:

Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Auckland
Ph: 0800 174 104

Made in France.

® Registered Trademark

This leaflet was prepared in March 2017.

Published by MIMS August 2017

BRAND INFORMATION

Brand name

Rozex Gel

Active ingredient

Metronidazole

Schedule

S4

 

1 Name of Medicine

Metronidazole.

2 Qualitative and Quantitative Composition

Rozex Gel contains metronidazole 7.5 mg/g in an aqueous gel.

Excipients with known effect.

Contains hydroxybenzoates.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Rozex Gel is a colourless to pale yellow viscous and homogeneous gel with no foreign matter.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of inflammatory papules, pustules and erythema of rosacea.

4.2 Dose and Method of Administration

Adults.

Apply and rub in a thin film of gel twice daily, morning and evening, to entire affected areas of the skin after washing.

Elderly.

The dosage recommended in the elderly is the same as that recommended in adults.

Children.

Not recommended.
Areas to be treated should be cleansed before application of gel. Patients may use cosmetics after application of the product.
Significant therapeutic results should be noted within three weeks. Clinical studies have demonstrated continuing improvement over nine weeks of therapy. In the absence of a clear clinical improvement, therapy should be stopped.
The average period of treatment is usually of three to four months. The recommended duration of treatment should not be exceeded.

4.3 Contraindications

Contraindicated in individuals with a history of hypersensitivity to metronidazole, hydroxybenzoates or other ingredients of the formulation.

4.4 Special Warnings and Precautions for Use

Rozex has been reported to irritate the eyes (watering), therefore contact with the eyes and mucous membranes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently, discontinue use temporarily or discontinue use until further instructions. Metronidazole is a nitroimidazole compound and should be used with care in patients with evidence or a history of blood dyscrasia.
Metronidazole transforms into inactive metabolite due to UV exposure, therefore its efficacy decreases significantly. Phototoxic side-effects haven't been reported in clinical trials in relation to metronidazole.
Patients should be advised to avoid or minimise exposure of areas treated with topical metronidazole to sunlight or other sources of UV light (see Section 5.3 Preclinical Safety Data, Carcinogenicity). Unnecessary or prolonged use of this medication should be avoided, as the long-term safety of topical metronidazole is unknown.

Use in the elderly.

No data available.

Paediatric use.

Rozex (metronidazole 0.75%) gel has not been studied in children. Rosacea is a skin disorder which principally affects adults. Rozex is not recommended for use in children due to a lack of data on safety and efficacy.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Drug interactions are less likely with topical administration but should be kept in mind when Rozex is prescribed for patients who are receiving anticoagulant treatment. Nevertheless, it should be mentioned that disulfiram-like reactions has been reported in small number of patients taking metronidazole and alcohol concomitantly.
Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin is not known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Oral metronidazole caused hypospermatogenesis, infertility and abnormal spermatozoa in mice and rats with a NOEL in rats being about 200 times the estimated human metronidazole dose contained in the Rozex Gel, based on body surface area.
(Category B2)
There is no experience to date with the use of Rozex in pregnancy. In case of oral administration, metronidazole crosses the placental barrier and rapidly enters the foetal circulation. There is inadequate evidence of the safety of metronidazole in human pregnancy. In animal studies metronidazole was not teratogenic or embryotoxic unless administered at extremely high doses. Because there are no well-controlled studies of therapy with Rozex Gel in pregnant women, Rozex Gel should not be used during pregnancy.
 After oral administration metronidazole is excreted in breast milk in concentrations similar to those found in the plasma. Metronidazole blood levels from topical application are significantly lower than those achieved after oral metronidazole. A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Because of the minimal absorption of metronidazole, and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug have not been reported with Rozex. Adverse reactions reported with Rozex include eye irritation (watering) if the gel is applied too closely to this area, transient redness, mild dryness, burning and skin irritation. None of the side effects exceeded an incidence of 2% of patients.
The following spontaneous adverse experiences have been reported, and within each system organ class, are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/ 1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports.

Skin and subcutaneous tissue disorders.

Common: dry skin, erythema, pruritus, skin discomfort (burning, pain of skin/stinging), skin irritation, worsening of rosacea. Unknown frequency: contact dermatitis, skin exfoliation, swelling face (*), seborrhoea, skin infection, sunburn, urticaria.

Nervous system disorders.

Uncommon: hypoesthesia, paraesthesia, dysgeusia (metallic taste), dizziness.

Gastrointestinal disorders.

Uncommon: nausea, gastritis.

Respiratory system disorders.

Uncommon: bronchitis, rhinitis.

Endocrine disorders.

Rare: hypothyroidism.

Musculoskeletal.

Rare: bursitis, myalgia, osteoporosis.

Special senses.

Rare: conjunctivitis.

Body as a whole.

Uncommon: abscess, accidental injury, flu symptom, infection.

Post-marketing experience.

The following non-serious adverse experiences have been reported since 1995: contact dermatitis/ allergic reaction; skin exfoliation, swelling face, local irritation, erythema, pruritus, burning, dryness, tightness, discomfort, rash, hyperpigmentation, pigmentation disorders, hypertrichosis, facial oedema, eyelid oedema, treatment failure (worsening of rosacea); watery eyes, metallic taste, tingling or numbness in the extremities, nausea, other (zoster lesion, pustules on the nose and vesicular bullous eruptions). The causal relationship with topical metronidazole has not been unequivocally established for these adverse experiences.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

There is no human experience with overdosage of Rozex. The acute oral toxicity of the Rozex formulation was determined to be greater than 5 g/kg (the highest dose given) in albino rats.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Metronidazole is an antiprotozoal (trichomoniasis, amoebiasis, giardiasis) and anaerobic antibacterial agent. However, the mechanisms by which Rozex acts in reducing inflammatory lesions of rosacea are unknown, but may include an antibacterial and/or anti-inflammatory effect.

Clinical trials.


5.2 Pharmacokinetic Properties

The absorption of metronidazole following topical administration is negligible. Studies on the topical administration of 1 gram of Rozex (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanogram/mL in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg, which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole.

5.3 Preclinical Safety Data

Genotoxicity.

Metronidazole has shown evidence of mutagenic activity in several bacterial systems. In addition, a dose response increase in the frequency of micronuclei was observed in mice after intraperitoneal injection and an increase in chromosome aberrations has been found in human lymphocyte cultures. The benefit/risk ratio should therefore be carefully assessed in each case particularly in relation to the severity of the disease and the age of the patient.

Carcinogenicity.

Animal studies with oral metronidazole showed increased incidences of tumour in the lung, liver, testes, reticulum, mammary gland and pituitary gland in certain rodent species. Evidence of photocarcinogenicity of metronidazole has also been reported in mice. Although there is no evidence to date of a carcinogenic effect in humans it is prudent to avoid unnecessary and prolonged use of Rozex Gel and to avoid or to minimise exposure of sites treated with Rozex Gel to the sun.

6 Pharmaceutical Particulars

6.1 List of Excipients

Methyl and propyl hydroxybenzoates, propylene glycol, carbomer 940, disodium edetate, sodium hydroxide and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Gel.

2 g, 5 g, 15 g, 30 g and 50 g tubes. Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Metronidazole is 1- (2 hydroxyethyl)-2-methyl-5-nitroimidazole. It is a white to brownish crystalline powder that is soluble in water.

Chemical structure.


C6H9N3O3; Mr 171.16.

CAS number.

443-48-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes